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TORISEL®(temsirolimus)

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TORISEL® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

TORISEL is indicated for the treatment of advanced renal cell carcinoma.

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2 DOSAGE AND ADMINISTRATION

2.1 Advanced Renal Cell Carcinoma

The recommended dose of TORISEL for advanced renal cell carcinoma is 25 mg administered as an...

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3 DOSAGE FORMS AND STRENGTHS

TORISEL (temsirolimus) is supplied as a kit consisting of the following:

TORISEL (temsirolimus) injection (25 mg/mL). The TORISEL vial contains temsirolimus at a concentration of 25 mg/mL....

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5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity/Infusion Reactions

Hypersensitivity/infusion reactions, including but not limited to flushing, chest pain, dyspnea,...

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6 ADVERSE REACTIONS

The following serious adverse reactions have been associated with TORISEL in clinical trials and are discussed in greater detail in other sections of the label [see

6.1...

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7 DRUG INTERACTIONS

7.1 Agents Inducing CYP3A Metabolism

Co-administration of TORISEL with rifampin, a potent CYP3A4/5 inducer, had no significant effect on...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings in...

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10 OVERDOSAGE

There is no specific treatment for TORISEL intravenous overdose. TORISEL has been administered to patients with cancer in phase 1 and 2 trials with repeated intravenous doses as high as 220 mg/m...

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11 DESCRIPTION

Temsirolimus, an inhibitor of mTOR, is an antineoplastic agent.

Temsirolimus is a white to off-white powder with a molecular formula of C56H87NO...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Temsirolimus is an inhibitor of mTOR (mammalian target of rapamycin). Temsirolimus binds to an intracellular protein...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with temsirolimus. However,...

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14 CLINICAL STUDIES

A phase 3, multi-center, three-arm, randomized, open-label study was conducted in previously untreated patients with advanced renal cell carcinoma (clear cell and non-clear cell histologies). The...

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15 REFERENCES

  1. OSHA Hazardous Drugs. OSHA. https://www.osha.gov/SLTC/hazardousdrugs/index.html.
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16 HOW SUPPLIED/STORAGE AND HANDLING

NDC 0008-1179-01 TORISEL (temsirolimus) injection, 25 mg/mL.

Each kit is supplied in a...

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17 PATIENT COUNSELING INFORMATION

Allergic (Hypersensitivity/Infusion) Reactions

Patients should be informed of the possibility of serious...

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This product's label may have been updated. For full prescribing information, please visit www.torisel.com.

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